Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage

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ClinicalTrials.gov Identifier: NCT00565552

Recruitment Status : Unknown

Verified November 2007 by University Hospital Schleswig-Holstein.
Recruitment status was: Recruiting

First Posted : November 30, 2007

Last Update Posted : November 30, 2007

Sponsor:

Information provided by:

University Hospital Schleswig-Holstein

Tracking Information

First Submitted Date ^ICMJE

November 29, 2007

First Posted Date ^ICMJE

November 30, 2007

Last Update Posted Date

November 30, 2007

Study Start Date ^ICMJE

January 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.) [ Time Frame: 45 minutes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

allergic reaction compliance [ Time Frame: retrospective ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage

Official Title ^ICMJE

Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction

Brief Summary

So far the evaluation of scar treatment was based on subjective criteria. The patient groups were divided into treated versus non-treated.

In this study we use patients undergoing ear reconstruction with autologous rib cartilage. The thoracic scar of harvesting the rib cartilage is routinely reopened after 3 month during second stage of reconstruction. Therefore we have a ideal model of clinical, physiological and histological scar evaluation in a homologous patient group.

All patients randomly treat one half of the scar with a silicone gel (Dermatix). The other half is untreated as an internal control.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Cicatrix, Hypertrophic
Keloid

Intervention ^ICMJE

Drug: Silicone gel (Dermatix®)

The half one the scar to treat was randomised among patients. After regular cleaning of the skin around the scar one half was thinly creamed with the silicone gel from medial to lateral and let dry for 5 minutes. It was done twice daily.

Other Name: Dermatix®

Study Arms ^ICMJE

Active Comparator: 1

Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control.

Intervention: Drug: Silicone gel (Dermatix®)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

January 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients with high grade microtia requiring a reconstruction with autologous rib cartilage

Exclusion Criteria:

diabetes mellitus
vascular disease
known allergic reaction to silicone

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

9 Years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00565552

Other Study ID Numbers ^ICMJE

Dermatix01

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Dr. Stefan Nitsch, University of Schleswig-Holstein

Study Sponsor ^ICMJE

University Hospital Schleswig-Holstein

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stefan Nitsch, MD

University Hospital Schleswig-Holstein

PRS Account

University Hospital Schleswig-Holstein

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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